3D Printed Biodegradable Cervical Interbody Fusion Cage in Anterior Cervical Discectomy and Fusion，a Small Sample and Exploratory Research
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Radiologic evaluation
研究概览
简要总结
A small sample, single center, non-randomized, noninferiority clinical trial to evaluate the safety and effectiveness of 3D printed biodegradable cervical interbody fusion cage in anterior cervical discectomy and fusion (ACDF) for treating patients with a symptomatic degenerative cervical disc disease at one level from C2/C4 to C7/T1.
详细描述
The study will evaluate if 3D printed biodegradable cervical interbody fusion cage is non-inferior to poly-ether-ether-ketone (PEEK) cage in single-level ACDF with the use of local autologous bone. 3D printed biodegradable cervical interbody fusion cage is a restorable cervical interbody cage for the treatment of fusion, following discectomy, of the cervical spine from C2/C4 disc space to the C7/T1 disc space. The material used to prepare the implant is a mixture of polycaprolactone (PCL) and tricalcium phosphate (TCP), which is called PCL-TCP. The implant has proper strength and connective porosity. The PCL-TCP cage is intended to be used with a supplemental fixation system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature patients aged between 25 and 85 years (inclusive);
- •Symptomatic cervical disc disease (SCDD) in the vertebral level between C2/C3 to C7/T1, correlated with radiculopathy or myelopathy;
- •Radiographic confirmation (by CT, MRI, x-ray, etc.) of any of the following: herniated nucleus pulposus, spondylosis or loss of disc height;
- •Requires only one cervical vertebral level to be surgically treated;
- •Failed at least 12 weeks of conservative treatment;
- •Patient must understand and sign the Informed Consent document that has been approved by the Ethics committee;
- •No significant restrictions showed by the pre-surgical routine test and examination.
排除标准
- •Skeletally immature patients;
- •Prior radiation history at anterior cervical area;
- •Prior surgery at the level to be treated;
- •More than one vertebral level requiring treatment, confirmed radiologically by X-ray, CT, or MRI
- •Complication of ossification of the ligamentum flavum, and Ossification of the posterior longitudinal ligament;
- •Clinically compromised vertebral bodies at the affected level(s) due to trauma or tuberculosis
- •Severe osteoporosis;
- •Active systemic or local infection;
- •Participation in other investigational device or drug clinical trials within 3 months of surgery;
- •Other patients whom the investigator believe not appropriate.
结局指标
主要结局
Radiologic evaluation
时间窗: 12 months
Radiologic fusion assessed by roentgenographic examination or CT scan
次要结局
- Japanese Orthopaedic Association Scores (JOA scores)(12 months)
- Measurement of Pain: Visual Analog Scale (VAS)(12 months)